I am seeing good things for AXIM coming down the road, but not nearly as amazing as I once thought. Still good, though.
Axim has completely (100%) severed its ties with Empowered, so there is no expectation of anything from the EU or CA either. Sadly for Empowered, Empowered is now on the FDA's permanent Schiff List. Empowered most likely will never be able to obtain an EUA or even a 510(k) for anything ever again. I'm guessing Empowered failed miserably at "pay to play." So goes the politics of the Present Politically Corrupt Party in Charge (PPCPIC).
Axim presumably (as per their website) would still be interested in pursuing an EUA in the US for retail (diagnostic) purposes, and approvals in CA and the EU as well, but only if - as was the case with Empowered - another manufacturing partner were to come along and foot all the expenses necessary to make that happen (as did Empowered). Unfortunately, after having seen the (unfair?) beating Empowered was handed down by the FDA, I personally don't think anyone is going to jump on that sword any time soon.
Axim is now marketing Immunopass as "Research Use Only" (RUO), which enables Axim to sell Immunopass immediately, and at a much higher price per unit. Retail sales would have had to be about $12-$15 per unit in order to be successful. Research use, on the other hand, has a much higher mark-up and the ability to pay much more (2 1/2 to 3 1/2 times as much), since the features associated with Immunopass still beat all of its competitors hands down. Of course, the number of kits for RUO will only be a fraction of what Axim would have seen had they gotten their EUA, but the premium ("profit" per test kit) will be greater. Still a huge plus for Axim, but not nearly what we were hoping for.
As for the DED line, it looks like the two approved test kits are being used presently to work out any of the bugs before going to market, so I am now guessing sales (and revenues from sales) won't begin showing up till Q2.
I recently spoke with someone familiar with 510(k)s, and the newest test (the one that detects the biomarker MMP-9) could very well get 510(k) approval this year, since the research and the link between MMP-9 and DED have already been conclusively established. (The biggest problem with Immunopass was that there wasn't any conclusive research out there as of yet that could precisely establish the level of Nabs necessary to prevent infection!).
So there is the possibility and potential that the newest DED test kit also could hit the market before the end of this year.
The DED line is definitely now Axim's primary product line, and Axim is truly doing an amazing job at accumulating the world renowned talent to make this line a success.
Bottom Line: With the expectation and hopes of an EUA from the FDA being removed, that part of the high risk/high reward equation is gone as well. Any short-term investment in Axim should be made with respect to their (much less risky) DED line, with Immunopass Research Use Only sales being considered a small added plus, and the cancer line being considered for its long term potential.
News 
Market Data 
Discover 
